Energy based dissection devices are known. For example, U.S. Pat. No. 8,241,313 discloses a surgical cutting instrument for use with a drive motor, and related system and method, is described. The surgical cutting instrument includes an elongated drive member, a cutting tip secured to the drive member, a non-conductive coupling body adapted for connection to a motor assembly, a housing maintaining the coupling body, a fluid coupling assembly and an electrical connector for connection to a stimulating energy source. The electrical connector is in electrical communication with the cutting tip via an electrical pathway.
In another example, Ethicon Endo-Surgery, Inc. discloses their HARMONIC ACE® shears, a sterile, single-patient-use device consisting of an ergonomic grip housing assembly and two hand-controlled power settings. The HARMONIC ACE® shears employ an adaptive tissue technology enabling the generator to actively monitor the instrument during use, allowing the system to respond intelligently to varying tissue conditions. Electrical energy is converted to mechanical energy.
Nerve monitoring devices are also known. For example, U.S. Pat. No. 7,991,463 discloses systems for determining structural integrity of a bone within the spine of a patient, the bone having a first aspect and a second aspect, wherein the second aspect separated from the first aspect by a width and located adjacent to a spinal nerve. A stimulator is configured to generate an electrical stimulus to be applied to the first aspect of the bone. A monitor is configured to electrically monitor a muscle myotome associated with the spinal nerve to detect if an onset neuro-muscular response occurs in response to the application of the electrical stimulus to the first aspect of the bone. An adjuster is configured to automatically increase the magnitude of the electrical stimulus to until the onset neuro-muscular response is detected. Lastly, a communicator is configured to communicate to a user via at least one of visual and audible means information representing the magnitude of the electrical stimulus which caused the onset neuro-muscular response.
In another example, U.S. Pat. No. 7,972,284 discloses a method of preventing nerve damage positional injury during surgery includes providing a nerve damage positional injury pressure monitoring system including a site sensor with a transducer in the form of a transducer element and a ring extending outward from the transducer element, and a monitor connected to the site sensor; adhering the ring of the site sensor to the patient so that the transducer element forms a protective barrier in front of the area of the patient prone to nerve damage positional injury during surgery; using the system to continuously monitor pressure on the protective barrier formed by the transducer element in front of the area of the patient prone to nerve damage positional injury during surgery with the site sensor and monitor; and causing an alarm to be actuated to alert medical personnel of a pressure condition when monitored pressure is greater than a predetermined threshold.
In another example, U.S. Pat. No. 7,214,197 discloses an intraoperative neurophysiological monitoring system includes an adaptive threshold detection circuit adapted for use in monitoring with a plurality of electrodes placed in muscles which are enervated by a selected nerve and muscles not enervated by the nerve. Nerve monitoring controller algorithms permit the rapid and reliable discrimination between non-repetitive electromyographic (EMG) events repetitive EMG events, thus allowing the surgeon to evaluate whether nerve fatigue is rendering the monitoring results less reliable and whether anesthesia is wearing off. The intraoperative monitoring system is designed as a “surgeon's monitor,” and does not require a neurophysiologist or technician to be in attendance during surgery. The advanced features of the intraoperative monitoring system will greatly assist neurophysiological research toward the general advancement of the field intraoperative EMG monitoring through post-surgical analysis. The intraoperative monitoring system is preferably modular, in order to allow for differential system pricing and upgrading as well as to allow for advances in computer technology; modularity can also aid in execution of the design.
In another example, U.S. Pat. No. 7,006,863 discloses a method and an apparatus for simultaneously assessing the functional status of component parts of the nervous system by presenting sparse stimuli to one or more parts of the sensory nervous system. Sparse stimuli consist of temporal sequences of stimulus conditions presented against a baseline null stimulus condition, where the non-null stimulus condition, or conditions, are presented relatively infrequently. The low probability of encountering a stimulus differing from a baseline or null stimulus condition in sparse stimulus sequences insures that gain control mechanisms within the nervous system will increase the neural response magnitude and also bias the measured responses to those neurone populations having such gain controls. The consequently increased response amplitudes ensure more reliably recorded responses than are obtained with non-sparse stimuli.
In another example, U.S. Patent Application No. 2010/0145222 discloses a nerve monitoring system [that] facilitates monitoring an integrity of a nerve.
In another example, Medtronic discloses its NIM-Response® 3.0 nerve monitoring system, an innovative, intraoperative nerve integrity monitor enabling surgeons to identify and confirm motor nerve function and monitor major motor nerves by monitoring electromyographical (EMG) activity from multiple muscles during minimally invasive or traditional open surgeries and in response to a change in nerve function, providing visual and/or audible alerts. This system also implements artifact detection software for reducing noise and real-time continuous nerve monitoring with its APS™ Electrode.
There have also been attempts to combine the technology of dissection devices with nerve monitoring technology. For example, U.S. Pat. No. 8,050,769 discloses systems and methods for determining nerve proximity, nerve direction, and pathology relative to a surgical instrument based on an identified relationship between neuromuscular responses and the stimulation signal that caused the neuromuscular responses.
In another example, U.S. Pat. No. 5,928,158 discloses an improved surgical instrument which is used for cutting of tissue. The instrument includes a sensor which identifies nerves within the patient which are proximate to the cutting member of the instrument. The entire assembly is hand held and includes both a surgical cutter such as a scalpel blade, scissors, or laser scalpel, as well as the electronics to stimulate nerves within the patient. The electronics monitor is positioned near the tip of the instrument to warn the surgeon of a proximate nerve so that the nerves are not inadvertently severed. In one embodiment of this invention, the scissors are incapacitated when a nerve is sensed to prevent an accidental cutting of the nerve.
In another example, U.S. Patent Application No. 2010/0198099 discloses a signal processing module includes an input module electronically coupled to a sensing probe of a nerve integrity monitoring system. The probe senses electrical signals from a patient during operation of an electrosurgical unit. The input module receives an input signal from the probe. An EMG detection module is coupled to the input module and is adapted to detect conditions in the input signal. The conditions are classified as a function of a level of electromyographic activity. An output module, coupled to the EMG detection module, provides an indication of electromyographic activity in the input signal based on the detected conditions.
In another example, U.S. Patent Application No. 2014/0267243 discloses a surgical scalpel, scalpel instrument and/or scalpel system (collectively, scalpel), particularly designed for use in a transverse carpal ligament surgical procedure, that evaluates an incision path with respect to a nerve in the incision path, and is used to perform the incision if appropriate. The scalpel emits an evaluation signal through a potential incision path through tissue captured by the scalpel. The scalpel utilizes the emitted evaluation signal to determine the presence of a nerve in the incision path. The dissection and evaluation (surgical) instrument includes a blade that is retractable relative to a target tissue capture area thereof. Evaluation may include determining the presence of a nerve before incision and/or the evaluating whether the target tissue has been appropriately captured. A warning is provided when the evaluation determines that a nerve is in the incision path and/or when the captured target tissue is determined to be inappropriate. Alternatively, the surgical instrument may disable extension of the blade when the evaluation determines that a nerve is in the dissection path and/or when the captured target tissue is determined to be inappropriate.
Therefore, there remains an unmet need for the system and method of the invention of the present application that operatively connects nerve monitoring technology and energy based dissection technology to provide a device that provides energy based dissection functionality wherein said energy based dissection technology cannot operate, or operates differently, upon receipt of real time information from the nerve monitoring functionality that nerve damage may be imminent in the absence of such safety shutdown and removing human error and reaction time issues which prevents unintended dissection and concomitant nerve damage.